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FDA addresses drugs, bioengineered plants

(Wednesday, Sept. 11, 2002 -- CropChoice news) --

September 9, 2002, USA Today, Elizabeth Weise: The Food and Drug Administration has released long-awaited guidelines listing what drug developers must do to prove the safety and effectiveness of drugs made from bioengineered pharmaceutical plants.

Such plants have been manipulated by DNA technology to produce drug products. It's cheaper and easier than manufacturing them in factories. No drugs currently sold in the USA are produced this way, but several are being tested.

Under the guidelines released Friday, plants used to produce drugs should be chosen so that they don't contain allergenic compounds and can't spread easily.

If the plant producing the drug is also a food-crop species, the company must take steps ensure that it will not get into the food supply. This might mean inserting a genetic marker to make it a different color or changing the conditions under which it will grow. For plants that can easily cross-pollinate, the FDA suggests growing the genetically altered form in a part of the country where its food counterpart isn't normally grown: corn in Alaska, or peanuts in Arizona.

The guidelines distinguish between contamination of the drug product itself and contamination of the environment by the genetically modified plant. "Our focus is on environmental issues that pertain to having a safe product," says FDA's Eric Flamm. The Department of Agriculture will be responsible for the safety of the environment as a whole, he says.

Recognizing the need to modernize the regulatory process to keep up with technology is a good first step, says Michael Fernandez of the non-profit Pew Initiative on Food and Biotechnology. "But the devil's in the details. The implementation is going to tell whether it satisfies the various stakeholders."

Gregory Jaffe of the Center for Science in the Public Interest says the FDA didn't go far enough. It didn't set up mechanisms to ensure safety if the products get in the food system and didn't specify strong enforcement to make sure the plants are contained, he says.